MAUDE Adverse Event Report: APIFIX LTD MID-C 125; POSTERIOR RATCHETING ROD SYSTEM

Model Number MID-C 125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Patient has been revised to remove the implants without performing fusion, the reason: wound infection.

Manufacturer Narrative

Investigation: production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.Patient/ surgeon information: this is the second revision surgery of this patient (previous is incident no (b)(4)).The patient was initially operated on (b)(6) 2016.During surgery the upper screw was misplaced.The screw was later revised, and its correct placement was confirmed via ct.Post-op the patient had a dural leak and a wound complication of the lower surgical wound.The company does not know for certainty if vancomycin powder was applied in this procedure but estimates with high certainty based on the surgeon previous practice that vancomycin was not applied in the present case.Risk assessment: the risk of infection late is a known risk.The current rate of this event is (b)(4) and is in line with the rate reported in the literature for this type of complication as described in the company's clinical evaluation report (b)(4).The event of wound complication addressed in the ifu ((b)(4)) as potential risks associated with the mid-c system.The risk of the screw pull out has been assessed and found to be acceptable (dms# (b)(4)).Corrective action: following the 2019 pms report ((b)(4)), the company decided to open capa (b)(4) to address an increase in late infection complaints.As part of the capa the company: performed a vast literature search to identify the late infection rate reported in the literature ((b)(4)).Investigated production lots associated with late infection.The compared antibiotic protocol used between centers.Received consultation by an infection specialist.The capa investigation did not identify a manufacturing problem with implants used in patients that developed a late infection and the late infection rate noted was within the rate reported in the literature.The company did however identify that sites applying vancomycin powder before wound closure have a significantly lower rate of late infection complaints.The use of vancomycin powder was also supported by the infection specialist consultation ((b)(4)).The company communicated these findings of applying vancomycin powder before wound closure to the surgeons ((b)(4)) and is continuing to follow the rate of late infection complaints.

• Brand Name: MID-C 125
• Type of Device: POSTERIOR RATCHETING ROD SYSTEM
• Manufacturer (Section D): APIFIX LTD; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer (Section G): APIFIX LTD; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692 07; IS 2069207
• Manufacturer Contact: adi prager ; 1 hacarmel street; kochav yokneam bldg; yokneam elit, 20692-07 ; IS 2069207
• MDR Report Key: 13928558
• MDR Text Key: 288206570
• Report Number: 3013461531-2022-00012
• Device Sequence Number: 1
• Product Code: QGP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: H170001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 05/17/2021
• Device Model Number: MID-C 125
• Device Catalogue Number: AF 125
• Device Lot Number: AF 08-01-16
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/28/2022
• Date Device Manufactured: 05/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention